Z-0915-05

ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent

Name: Z-0915-05 ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
Creator: Instrumentation Laboratory Co.
Published: 2005-05-19
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2005-05-19 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent on 2005-05-19. The reason FDA records is "Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0915-05
Status: Terminated
Initiated: 2005-05-19
Posted: 2005-06-21
Terminated: 2006-12-06
Recalling firm: Instrumentation Laboratory Co.
Product: ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
FDA root cause: Other
Action: Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005.
Quantity in commerce: 617 units
Distribution: Nationwide Canada
Product codes and lots: Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354

Product code JPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)